Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma

Exclusion Criteria

• •1. Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome
• •2. Plasma cell leukemia
• •3. Grade 2 peripheral neuropathy within 14 days before enrollment
• •4. Impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or greater heart failure, Uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or Multigated acquisition(MUGA) scan evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment, electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• •5. Severe hypercalcemia, i.e., serum calcium 12 mg/dL (3.0 mmol/L) corrected for albumin
• •6. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• •7. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• •8. Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a patient with a recent history of kyphoplasty with the medical monitor).
• •9. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
• •10. Received the following prior therapy:
• •* Chemotherapy within 3 weeks of enrollment (6 wks for nitrosoureas)
• •* Corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks of enrollment
• •* Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide or bortezomib within 21 days before enrollment
• •* Radiation therapy within 28 days before enrollment, except localized radiation therapy
• •* Use of any other experimental drug or therapy within 28 days of enrollment
• •11. Known hypersensitivity to compounds of similar to thalidomide, doxorubicin, bortezomib, boron or mannitol.
• •12. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• •13. Concurrent use of other anti-cancer agents or treatments
• •14. Known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required